FDA 510(k) Application Details - K151869

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

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510(K) Number K151869
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND
ESPENSTRASSE 139
WIDNAU 9443 CH
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Contact GERHARD FRICK
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Regulation Number 870.1130

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Classification Product Code DXN
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Date Received 07/09/2015
Decision Date 09/02/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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